Thermo Fisher Scientific plans to develop a companion diagnostic for Eli Lilly’s Phase I/II cancer candidate LOXO-292. The companion diagnostic will be based on Thermo Fisher's Oncomine Dx Target Test (pictured). [Thermo Fisher Scientific].

Thermo Fisher Scientific said today it will develop a companion diagnostic for Eli Lilly’s Phase I/II cancer candidate LOXO-292 (selpercatinib) through a collaboration whose value was not disclosed.

The companion diagnostic will use Thermo Fisher’s next-generation sequencing-based Oncomine Dx Target Test to identify certain non-small cell lung cancer (NSCLC) and thyroid cancer patients who may be treated with LOXO-292, which Lilly is developing through its wholly-owned subsidiary Loxo Oncology.

Thermo Fisher said the test would be used with patients whose tumors harbor a RET alteration. RET variants are found in about 2% of NSCLC cases, about 60% of medullary thyroid cancer (MTC), and up to approximately 20% of other thyroid cancers, according to the company.

“We are committed to working with our global pharmaceutical partners to help bring forth next-generation sequencing-based companion diagnostics and best-in-class therapies that can have a profound impact on treating cancer patients,” Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific, said in a statement.

Thermo Fisher will retain rights to commercialize the test in all markets, including the U.S., Europe and Japan. Once validation is complete, Thermo Fisher said, it will submit a supplemental premarket approval (sPMA) application to the FDA to broaden the clinical claims of its Oncomine Dx Target Test.

Oncomine Dx Target Test simultaneously screens tumor samples for multiple gene variants associated with NSCLC, a subset of which are used to identify patients who may be eligible for several approved targeted therapies. The test received FDA approval in 2017, and has since received positive reimbursement decisions from the Centers for Medicare & Medicaid Services and a majority of the largest commercial U.S. health plans.

Oncomine Dx Target Test is also approved for reimbursement by the Japan Ministry of Health, Labor and Welfare (MHLW).

LOXO-292 is a first-in-class oral rearranged during transfection (RET) inhibitor being developed to treat advanced cancers that harbor activating alterations of the RET kinase.

Today at the 2019 World Conference on Lung Cancer (WCLC) in Barcelona, Spain, Lilly presented positive data from the LIBRETTO-001 clinical trial (NCT03157128) for LOXO-292 in treating RET fusion-positive non-small cell lung cancer (NSCLC).

Of the first 105 enrolled RET fusion-positive NSCLC patients with prior platinum-based chemotherapy, selpercatinib treatment resulted in a 68% objective response rate, rising to an 85% ORR in treatment-naïve RET fusion-positive NSCLC patients. Median duration of response (DOR) was 20.3 months, while median progression-free survival (PFS) was 18.4 months, Lilly said.

LOXO-292 is among pipeline candidates Lilly inherited when it signaled its intent to become a top-tier precision oncology company by acquiring Loxo Oncology for $8 billion, a deal completed on February 15.

Lilly noted that changes in the RET kinase, including fusions and mutations, can cause uncontrolled cell growth leading to tumor development. Cancers driven by such alterations are mostly dependent on activation of that pathway, making them highly susceptible to small molecule inhibitors, Lilly reasons.

“With this agreement, we believe that more patients will gain access to high-quality tumor profiling, identifying those with RET alterations potentially suitable for LOXO-292 therapy, in addition to other alterations suitable for treatment with other therapies,” stated Anne White, president of Lilly Oncology.

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